Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | COOK BIRD'S NEST VENA CAVA FILTER |
Generic Name | FILTER, INTRAVASCULAR, CARDIOVASCULAR |
Regulation Number | 870.3375 |
Applicant | COOK, INC. P.O. BOX 489 BLOOMINGTON, IN 47402 |
PMA Number | P850049 |
Supplement Number | S005 |
Date Received | 02/06/1995 |
Decision Date | 09/17/1996 |
Reclassified Date
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05/01/2000 |
Product Code |
DTK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REVISED LABELING |
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